Summary of CMS Initiative for Point of Care COVID-19 Testing in
The Trump Administration today announced HHS would embark on a one-time procurement of rapid point-of-care testing devices and tests to be distributed to nursing homes in COVID-19 hotspot areas of the United States.
Each nursing home will receive one diagnostic instrument – either the Quidel Sofia 2 Instrument or the BD Veritor Plus system – along with the associated tests. Following the initial distribution, nursing homes can procure additional tests directly from the respective manufacturer. All nursing homes must have the capability to screen and test residents at baseline, and test staff on a weekly basis or according to specific guidance by the state and local health departments. This procurement will also enable testing of visitors if appropriate for that facility.
Distribution will begin with nursing homes prioritized by CMS. The prioritization is based on CDC epidemiological hotspot data, as well as nursing homes that have reported the following information to the CDC by July 5th:
- Three or more confirmed or suspected new cases of COVID-19 within the last 7 days.
- At least one new COVID-19 case in the last 7 days after having zero previous COVID-19 cases.
- Inadequate access to testing within the last 7 days.
- At least one new resident death due to COVID-19 within the last 7 days.
- At least one new confirmed or suspected COVID-19 case among staff within the last 7 days.
Facilities that do not have a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver to administer the tests will not receive a testing instrument. Nursing homes can follow the CMS guidance to obtain a CLIA Certificate of Waiver.